IBD Neoplasia Surveillance Pilot RCT (IBDDysplasia)
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|ClinicalTrials.gov Identifier: NCT04067778|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Diseases Colonic Neoplasms Dysplasia||Diagnostic Test: Intervention Group Diagnostic Test: Control Group||Not Applicable|
Inflammatory Bowel Disease (IBD), including crohn's disease and ulcerative colitis, is a group of diseases characterized by acute and chronic inflammation of the intestinal tract. Persons with IBD are at an increased risk of developing colorectal cancer (CRC) and require frequent CRC screening with colonoscopy. Current IBD screening guidelines recommend the taking of biopsies of any lesions suspected to be pre-cancerous (targeted biopsies), as well as the taking of 30 to 40 random biopsies throughout the colon. The recommendations for random biopsies are based on historical practice and the theory that they would capture "invisible lesions", but are not supported by strong scientific evidence.
In fact, recent evidence has shown that random biopsies capture a very small number of pre-cancerous lesions and that they capture such lesions only in persons with additional risk factors for CRC. In addition, new colonoscopy practices and technology have made 80-90% of pre-cancerous lesions visible. Random biopsies also carry potential risks for patients, including lower gastrointestinal bleeding and bowel perforation, and substantially increase procedural costs and time.
Hence, there is a strong impetus to conduct a well-powered non-inferiority Randomized Controlled Trial (RCT) on this topic in a Canadian setting. With the support of a pan-Canadian IBD clinical trials alliance (the Canadian IBD Research Consortium (CIRC)), and the high prevalence of IBD in Canada, Canadian investigators are well-positioned to undertake such a trial. Before embarking on a large multi-center trial, a one-year pilot feasibility trial will be conducted to ensure that patients can be enrolled efficiently with excellent protocol compliance. A feasibility trial will also provide a crude estimate of the neoplasia detection rate (primary outcome) among persons with colon IBD (cIBD) in Canada, which will allow refinement of the sample size, recruitment period and budget for a definitive trial. To-date, no well-powered or North American RCTs have evaluated random biopsies as an intervention to guide our estimates for a definitive trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized, Parallel-Group, Non-Inferiority Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Screening in Adult Persons With Colonic Inflammatory Bowel Diseases: A Pilot Study|
|Actual Study Start Date :||November 6, 2020|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||October 31, 2022|
Experimental: Intervention Group
Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any pre-cancerous lesions observed by the doctor) and/or removal of any polyps will be undertaken.
Diagnostic Test: Intervention Group
Standard colonoscopy with targeted biopsies only
Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40) and targeted biopsies (and/or removal of any polyps) will be undertaken.
Diagnostic Test: Control Group
Standard colonoscopy with random AND targeted biopsies
- Overall Number of Participants Enrolled [ Time Frame: 1 year ]Number of participants enrolled within one year from the overall total required.
- Rate of Protocol Adherence [ Time Frame: 1 year ]Rate of protocol adherence of major protocol violations on a per-patient basis.
- Rate of overall neoplasia detection [ Time Frame: 1 year ]Overall neoplasia detection rate for the definitive trial.
- Adverse Events occurrence [ Time Frame: 2 weeks ]Occurrence of serious and minor post-procedural adverse events within 2 weeks of procedure.
- Rate of Study Variables [ Time Frame: 1 year ]
- Rate of Missed 2-Week Post-Procedural Assessment for Complications [ Time Frame: 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067778
|Contact: Lilia Antonova, PhD||613-737-8899 ext email@example.com|
|Contact: Janine Ryan, BA(Hon)||firstname.lastname@example.org|
|Eastern Regional Health Authority||Recruiting|
|St. John's, NFLD, Canada, A1B 3V6|
|Hamilton Health Sciences Corporation||Recruiting|
|Hamilton, Ontario, Canada, L8L 8E7|
|Ottawa Hospital Research Institute||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|